Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multipli mijelom - antineoplastična sredstva - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - tumori prostate, Кастраци-uporan - antineoplastična sredstva - treatment of adult patients with prostate cancer.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multipli mijelom - antineoplastična sredstva - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirin hidroklorid - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - edurant, u kombinaciji s drugim antiretrovirusne lijekove, je indiciran za liječenje humane imunodeficijencije tip 1 (hiv‑1) infekcija u bolesnika treatment‑naïve antiretrovirusne 12 godina i stariji sa viremija ≤ 100 000 hiv‑1 rna kopija/ml. kao i s drugim антиретровирусными lijekovima генотипическое ispitivanje otpora treba biti vođena pri korištenju edurant.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabin - leukemija, mieloid - antineoplastična sredstva - liječenje odraslih bolesnika s novodijagnosticiranom de novo ili sekundarne akutne mijeloične leukemije (aml), prema klasifikaciji svjetske zdravstvene organizacije (who), koji nisu kandidati za standardni kemoterapije.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidon palmitata - shizofrenija - psycholeptics - xeplion je indiciran za održavanje liječenja shizofrenije u odraslih pacijenata stabiliziranih paliperidonom ili risperidonom. in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international nv - danmavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international n.v.    - ponesimod - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Bosnien-Hercegovina - kroatisk - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

inpharm co. d.o.o. banja luka - bortezomib - prašak za rastvor za injekciju - 3.5 mg/1 viala - 1 bočica sa praškom za otopinu za injekciju sadrži: 3,5 mg bortezomib

Bosnien-Hercegovina - kroatisk - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

inpharm co. d.o.o. banja luka - ibrutinib - kapsula, tvrda - 140 mg/1 kapsula - 1 kapsula, tvrda sadrži: 140 mg ibrutiniba